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Generic

Tadalafil

Indications

Tadalafil is used to treat erectile dysfunction (ED)-

• Erectile Dysfunction (ED)
• Benign Prostatic Hyperplasia (BPH)
• Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia

Pharmacology

Tadalafil is a PDE5 inhibitor that works selectively. Smooth muscle cells produce more cGMP when PDE5 is inhibited. cGMP induces penile erection by relaxing smooth muscles and increasing blood flow to the corpus cavernosum. PDE5 is also found in the prostate and bladder wall smooth muscles. PDE5 inhibition raises cGMP levels, causing smooth muscle relaxation in the prostate and bladder. Smooth muscle relaxation may increase blood flow to the urinary system and expand the bladder neck opening, resulting in better voiding.

Dosage & Administration

Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.

Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.

Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.

Interaction

Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesium hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin, and Phenobarbital are examples.

Contraindications

• Use of nitrates (e.g., Nitroglycerine, Isosorbide): Nitrates' hypotensive effects may be exacerbated.
• Tadalafil hypersensitivity reactions

Side Effects

Common side effects include headache, dyspepsia, back discomfort, myalgia, nasal pharyngitis, and nasal congestion. Changes in color vision, sudden vision loss, hearing loss, Stevens-Johnson Syndrome, exfoliative dermatitis, angina, stroke, myocardial infarction, severe hypotension, and tachycardia are all unusual but possible complications.

Pregnancy & Lactation

The USFDA has classified tadalafil as pregnancy category B. Tadalafil should only be used during pregnancy if the benefits exceed the risks. There is no information about Tadalafil excretion in human milk. When giving tadalafil to a breastfeeding mother, use caution.

Precautions & Warnings

Angina, renal impairment, hepatic impairment, and bleeding when using Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (such as Ritonavir, Ketoconazole, and Itraconazole), or other PDE5 inhibitors should all be avoided.

Therapeutic Class

Drugs for Erectile Dysfunction

Storage Conditions

Pharmaceutical Name

Euro Pharma Ltd.